PALO ALTO, Calif. & SHANGHAI & PRINCETON, N.J.--(BUSINESS WIRE)--LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, and BridgeBio Pharma, Inc. (Nasdaq: BBIO) today announced the first patient has been treated in a Phase 2a clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.
Infigratinib is a potent and selective FGFR inhibitor that has demonstrated compelling clinical activity across multiple tumor types with FGFR alterations, said Yizhe Wang, Ph.D., chief executive officer of LianBio. Given the disproportionately high prevalence rate of gastric cancer in China, LianBio is pursuing a region-specific development strategy focused on this area of great unmet need. This study marks LianBios first trial initiation and demonstrates our continued progress in delivering potentially transformational medicines to patients in Asia.
TRUSELTIQ (infigratinib) is an oral selective inhibitor of FGFR1-3 that is approved in the United States for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test. It is also being further evaluated in clinical trials based on demonstration of clinical activity in patients with advanced urothelial carcinoma with FGFR3 genomic alterations. LianBio in-licensed rights from BridgeBio for infigratinib for development and commercialization in Mainland China, Hong Kong and Macau.
The Phase 2a trial is a multicenter, open-label, single-arm study in China designed to evaluate the safety and efficacy of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR alterations. The primary endpoint is objective response rate (ORR). Secondary endpoints include duration of response, safety, disease control rate, progression-free survival and overall survival.
Preclinical data have demonstrated the potential infigratinib may have for patients with gastric cancer. These results, published in Cancer Discovery, demonstrated tumor regression in multiple in vivo FGFR2 amplified gastric models.1
We believe that infigratinib could have a meaningful impact for people living with gastric cancer as well as many other cancers with FGFR alterations, and are pleased LianBio is initiating this clinical trial in China where more therapeutic options are needed to match the growing diagnosis rate, said BridgeBio founder and chief executive officer Neil Kumar, Ph.D. On the heels of TRUSELTIQ recently obtaining accelerated approval in the United States, we are hopeful that this trial will yield pivotal results in another subset of cancer patients as we continue to build our portfolio of oncology indications with the aim of reaching as many people in need as possible.
About TRUSELTIQ (infigratinib)
TRUSELTIQ (infigratinib) is an orally administered, ATP-competitive, tyrosine kinase inhibitor of fibroblast growth factor receptor (FGFR) that received accelerated approval from the FDA in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. TRUSELTIQ targets the FGFR protein, blocking downstream activity. In clinical studies, TRUSELTIQ demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response. TRUSELTIQ is not FDA-approved for any other indication in the United States and is not approved for use by any other health authority, including any Chinese or other Asian health authority. It is currently being evaluated in clinical studies for first-line cholangiocarcinoma, urothelial carcinoma (bladder cancer), locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, and other advanced solid tumors with FGFR genomic alterations.
About BridgeBio Pharma, Inc.
BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBios pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the companys first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.
About LianBio
LianBios mission is to catalyze the development and accelerate availability of paradigm-shifting medicines to patients in China and other major Asian markets, through partnerships that provide access to innovative therapeutic discoveries with a strong scientific basis and compelling clinical data. LianBio collaborates with world-class partners across a diverse array of therapeutic and geographic areas to build out a broad and clinically validated pipeline with the potential to impact patients with unmet medical needs. For more information, please visit http://www.lianbio.com.
About the LianBio and BridgeBio Pharma, Inc. Strategic Alliance
In August 2020, LianBio entered into a strategic alliance with BridgeBio, a commercial-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, to develop and commercialize BridgeBios programs in China and other major Asian markets. This strategic relationship initially focuses on two of BridgeBios targeted oncology drug candidates: FGFR inhibitor infigratinib, for the treatment of FGFR-driven tumors, and SHP2 inhibitor BBP-398, in development for tumors driven by MAPK pathway mutations. The agreement also provides LianBio with preferential future access in China and certain other major Asian markets to more than 20 drug development candidates currently owned or controlled by BridgeBio. This collaboration is designed to advance and accelerate BridgeBios programs in China and other major Asian markets, allowing BridgeBio and LianBio to potentially bring innovation to large numbers of patients with high unmet need.
BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as anticipates, believes, estimates, expects, intends, may, plans, projects, seeks, should, will, and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act, and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to: the timing and success of the Phase 2a clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification, and other advanced solid tumors with FGFR genomic alterations; the planned approval of infigratinib by foreign regulatory authorities in China and the necessary clinical trial results, and timing and completion of regulatory submissions related thereto; and the competitive environment and clinical and therapeutic potential of infigratinib; reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation: the safety, tolerability and efficacy profile of infigratinib observed to date may change adversely in ex-U.S. clinical trials, ongoing analyses of trial data or subsequent to commercialization; foreign regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the continuing success of the BridgeBio and LianBio strategic alliance; and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent SEC filings, which are available on the SECs website at http://www.sec.gov. Except as required by law, each of BridgeBio and QED disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. Moreover, BridgeBio and QED operate in a very competitive environment in which new risks emerge from time to time. These forward-looking statements are based on each of BridgeBios and QEDs current expectations, and speak only as of the date hereof.
1 Guagnano, V., Kauffman, A., Wrle, S., et al. FGFR Genetic Alterations Predict for Sensitivity to NVP-BGJ398, a Selective Pan-FGFR Inhibitor. Cancer Discovery 2 (2012): 1118-1133.
- CRISPR: A game-changing genetic engineering technique - January 4th, 2023
- Genetic Counseling Online Course - School of Medicine Columbia ... - January 4th, 2023
- Genetics & Medicine - Site Guide - NCBI - National Center for ... - December 27th, 2022
- Lilly, ProQR to expand genetic medicine development agreement - December 27th, 2022
- Central Dogma and Genetic Medicine - HHMI BioInteractive - November 24th, 2022
- Social, Environmental, Cognitive, and Genetic Influences on the Use of ... - November 24th, 2022
- Genetically modified food controversies - Wikipedia - October 29th, 2022
- BSGM - The British Society for Genetic Medicine - October 13th, 2022
- Genetic and Genomic Medicine - Nationwide Children's Hospital - October 13th, 2022
- Carrier Screening for Genetic Conditions | ACOG - October 13th, 2022
- New NHS genetic testing service could save thousands of children in England - The Guardian - October 13th, 2022
- Vertex, after setbacks, moves forward with second-generation rare disease drug - BioPharma Dive - October 13th, 2022
- Passage Bio Announces Appointment of William Chou, M.D. as Chief Executive Officer - Yahoo Finance - October 13th, 2022
- Metagenomi Announces Participation in October Investor and Industry Conferences - Business Wire - October 4th, 2022
- NovaSeq X machines will make genetic analysis even faster and cheaper - Mezha.Media - October 4th, 2022
- ORYZON to Give Updates on Corporate Progress in October - BioSpace - October 4th, 2022
- e-therapeutics: Fundraise of 13.5 million - BioSpace - October 4th, 2022
- The inheritance of hope curing genetic heart disease now within grasp - British Heart Foundation - October 4th, 2022
- MS Genetic Counseling | Ohio State College of Medicine - September 16th, 2022
- Genetic Counselor - Mayo Clinic College of Medicine & Science - September 16th, 2022
- UCLA researcher awarded National Academy of Medicine prize for work on genetics of autism - Newswise - September 16th, 2022
- Medical research doesn't serve everyone. This effort hopes to build one of the most diverse health databases ever - Colorado Public Radio - September 16th, 2022
- Precision Medicine Offers Hope for More Targeted Rash Diagnosis and Treatment - Dermatology Times - September 16th, 2022
- Redmond firefighters to 'Fill the Boot' for Muscular Dystrophy Association - KTVZ - September 16th, 2022
- Why Monkeypox Wasnt Another COVID-19 - FiveThirtyEight - September 16th, 2022
- Endometriosis Researchers One Step Closer to Diagnosing Condition With Menstrual Blood - Business Wire - September 16th, 2022
- The Biggest CGT Breakthroughs Through the Eyes of Our 2022 Power List - The Medicine Maker - September 16th, 2022
- Humans evolved with their microbiomes like genes, your gut microbes pass from one generation to the next - The Conversation - September 16th, 2022
- When to Use Targeted Therapy for Iodine-Refractory Thyroid Cancer - Targeted Oncology - September 16th, 2022
- Gracell Biotechnologies to Participate in Three Upcoming Investor Conferences - PR Newswire - September 16th, 2022
- CRISPR is 10: A decade of gene editing refinements presents new ways to address agricultural diseases thought to be incurable - Genetic Literacy... - September 16th, 2022
- Sarepta Therapeutics Announces Recipients of Route 79, The Duchenne Scholarship Program, for ... - The Bakersfield Californian - September 8th, 2022
- 'Record' Gains in Bringing Research Closer to the Patient - Applied Clinical Trials Online - September 8th, 2022
- Metagenomi Announces Participation in September Investor and Industry Conferences - Business Wire - September 8th, 2022
- Sarepta Therapeutics Announces That FDA has Lifted its Clinical Hold on SRP-5051 for the Treatment of Duchenne Muscular Dystrophy - Yahoo Finance - September 8th, 2022
- Studies Reveal Aggressive Prostate Cancer Linked to Ancestral Heritage - DocWire News - September 8th, 2022
- Lonza and Touchlight collaboration will expands customer's access to DNA - Labiotech.eu - September 8th, 2022
- Genetic variants in miR-145 gene are associated with the risk of asthma in Taiwan | Scientific Reports - Nature.com - September 8th, 2022
- Elderly are more affected by COVID brain fog, but 'cognitive rehab' could be an effective treatment - Genetic Literacy Project - September 8th, 2022
- A therapy found to improve cognitive function in patients with Down syndrome - EurekAlert - September 8th, 2022
- Ovid turns to gene therapy startup to restock drug pipeline - BioPharma Dive - August 30th, 2022
- Morris Animal Foundation Golden Retriever Lifetime Study Celebrates 10 Years - PR Newswire - August 30th, 2022
- Immortal jellyfish genes identified that may explain their long lives - New Scientist - August 30th, 2022
- Walk Again Or Stop Blindness. How Gene Therapy Is Revolutionizing Medicine - Nation World News - August 30th, 2022
- ElevateBio and the University of Pittsburgh Announce Creation of Pitt BioForge BioManufacturing Center at Hazelwood Green to Accelerate Cell and Gene... - August 30th, 2022
- Therapeutic Effects of Tretinoin | JIR - Dove Medical Press - August 30th, 2022
- Physical Activity May Have a Stronger Role than Genes in Longevity - Newswise - August 30th, 2022
- BridgeBio, Baylor College of Medicine to Collaborate on Genetic Disease ... - August 22nd, 2022
- New $2.8-million gene therapy becomes most expensive medicine in history - New Atlas - August 22nd, 2022
- Molecular Map Reveals Insights Into the Genetic Drivers of CLL - The ASCO Post - August 22nd, 2022
- Biopharmaceutical Company Expands Clinical Trials On Texas A&M-Developed Angelman Syndrome Treatment - Texas A&M University Today - August 22nd, 2022
- Restrictive abortion laws are limiting the options parents have after receiving genetic test results, experts say - Yahoo News - August 22nd, 2022
- Marketing and Industry Trends Influencing Precision Medicine in 2022 - Healthcare Tech Outlook - August 22nd, 2022
- expert reaction to study investigating use of genetic risk score for prostate cancer in men with lower urinary tract symptoms to predict diagnosis -... - August 22nd, 2022
- As the Smithsonian wraps a genome exhibit, leaders in the field reflect - STAT - August 22nd, 2022
- Why some people suffer more from COVID-19 than others - EurekAlert - August 22nd, 2022
- Q3 2022 Earnings Forecast for LogicBio Therapeutics, Inc. Issued By William Blair (NASDAQ:LOGC) - Defense World - August 22nd, 2022
- Next generation patient avatars: Expanding the possibilities with MicroOrganospheres - EurekAlert - August 22nd, 2022
- Masters Program in Genetic Counseling - Perelman School of Medicine at ... - August 14th, 2022
- Admissions | Master's Program in Human Genetics & Genetic Counseling ... - August 14th, 2022
- The Silver Lining Of Innovation in Genetic Medicine - Pharmaceutical Executive - August 14th, 2022
- Genetics Team Serves as Go-to for Mom of Son With Extremely Rare Disorder - Stanford Medicine Children's Health Blog - Stanford Children's Health - August 14th, 2022
- UI professor receives grant from National Institutes of Health - Iowa Now - August 14th, 2022
- Lilly's Taltz (ixekizumab) Now Available in New, Citrate-Free Formulation to Reduce Injection Site Pain for Improved Patient Experience - PR Newswire - August 14th, 2022
- Research Roundup: 21 Genes Linked to Increased Risk of Alzheimer's and More - BioSpace - August 14th, 2022
- Personalised medicine made in hospitals can revolutionise the way diseases are treated the challenge now will be implementing it - The Conversation... - August 14th, 2022
- Beyond Paxlovid for covid-19: The hunt for better covid medications - Grid - August 14th, 2022
- PVM to Play Role in Research on New Patent-pending Method to Mass-produce Antitumor Cells to Treat Blood Diseases and Cancer - Purdue University - August 14th, 2022
- Analyzing Kiromic BioPharma (NASDAQ:KRBP) and LogicBio Therapeutics (NASDAQ:LOGC) - Defense World - August 14th, 2022
- Corporate America's Abortion Radicalism - The American Conservative - August 14th, 2022
- A team of Oxford and Mexican researchers want to diversify genomic databases. Can they end 'parachute science,' too? - STAT - August 14th, 2022
- The aging heart accumulates mutations while losing the ability to repair them - EurekAlert - August 14th, 2022
- Generation Bio Reports Business Highlights and Second Quarter 2022 Financial Results - GuruFocus.com - August 5th, 2022
- Population Genetic Testing: Save Lives And Money, While Avoiding Financial Toxicity - Forbes - August 5th, 2022
- Genetic Counselors Scramble Post- Roe to Provide Routine Pregnancy Services without Being Accused of a Crime - Scientific American - August 5th, 2022
- GENERATION BIO CO. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) - Marketscreener.com - August 5th, 2022
- Sangamo Therapeutics Reports Recent Business Highlights and Second Quarter 2022 Financial Results - Yahoo Finance - August 5th, 2022
- Researchers discover one of the largest known bacteria-to-animal gene transfer inside a fruit fly - EurekAlert - August 5th, 2022
- Intellia Therapeutics Announces Second Quarter 2022 Financial Results and Highlights Recent Company Progress - Yahoo Finance - August 5th, 2022
- Medical Student's Crime In Cipolletti: They Found A Man's DNA Under The Victim's Thumb - Nation World News - August 5th, 2022